NCT03387085

QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.

NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with TNBC who have progressed on or after previous SoC chemotherapy. Phase 2 will be based on Simon's two-stage optimal design.

Detailed description

Treatment will be administered in two phases, an induction and a maintenance phase, as described below. Subjects will continue induction treatment for up to 1 year. Treatment in the study will be discontinued if the subject experiences progressive disease (PD) or unacceptable toxicity (not corrected with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. Those who have a complete response (CR) in the induction phase will enter the maintenance phase of the study. Subjects who experience ongoing stable disease (SD) or an ongoing partial response (PR) at 1 year may enter the maintenance phase at the Investigator's discretion. Subjects may remain on the maintenance phase of the study for up to 1 year. Treatment will continue in the maintenance phase until the subject experiences PD or unacceptable toxicity (not corrected with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. The maximum time on study treatment, including both the induction and maintenance phases, is 2 years.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Aldoxorubicin HCl	Aldoxorubicin hydrochloride
BIOLOGICAL	N-803	Recombinant human super agonist interleukin-15 (IL-15) complex
BIOLOGICAL	ETBX-011	Ad5 \[E1-, E2b-\]-CEA
BIOLOGICAL	ETBX-051	Ad5 \[E1-, E2b-\]-Brachyury vaccine
BIOLOGICAL	ETBX-061	Ad5 \[E1-, E2b-\]-MUC1
BIOLOGICAL	GI-4000	Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
BIOLOGICAL	GI-6207	Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant CEA proteins
BIOLOGICAL	GI-6301	Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Brachyury yeast proteins
BIOLOGICAL	haNK for Infusion	NK-92 \[CD16.158V, ER IL-2\]
BIOLOGICAL	avelumab	Recombinant human anti-PD-L1 IgG1 monoclonal antibody
BIOLOGICAL	bevacizumab	Recombinant human anti-VEGF IgG1 monoclonal
DRUG	Capecitabine	5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
DRUG	Cisplatin	cis-diamminedichloroplatinum(II)
DRUG	Cyclophosphamide	2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
DRUG	5-Fluorouracil	5-fluoro-2,4 (1H,3H)-pyrimidinedione
DRUG	Leucovorin	L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt
DRUG	nab-Paclitaxel	Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
PROCEDURE	SBRT	Stereotactic Body Radiation Therapy

Timeline

• Start date: 2018-03-19
• Primary completion: 2020-09-11
• Completion: 2024-01-16
• First posted: 2017-12-29
• Last updated: 2024-08-09
• Results posted: 2024-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study